Quetiapine Sr as Adjunctive Treatment In Mixed States of Bipolar Disorder

Phase 4

Completed

Brief Summary: To assess the acute and long-term bimodal efficacy of QTP, as an adjunct to ongoing treatment with lithium (Li) or divalproex (DIV) or lamotrigine (LAM) or any combination of the three thereof, in a group of patients with an index episode of a mixed state in BD.

Recruitment & Eligibility

Inclusion Criteria

Male or female;
Age 18 years and older
Patients on:
- Li at a stable dose for 4 weeks or longer, and a serum level at screening of 0.5 mEq/l OR
- DIV dose for 4 weeks or longer, and a serum level at screening of 45 g/ml OR
- LAM (dosage/day ≥100mg) at a stable dose for 4 weeks or longer OR
- Any combination 3a, 3b, or 3c
Patients meeting DSM-IV TR diagnosis of bipolar disorder, I or II, as assessed using the MINI, (Sheehan et al., 1998) PLUS any ONE of criteria 5 or 6 or 7
Patients meeting DSM-IV TR diagnostic criteria for a mixed manic episode with Young Mania Rating Scale (YMRS) score>/=14 and Montgomery Asberg Depression Rating Scale (MADRS) score>/=14
Patients meeting the criteria for a manic/hypomanic episode for at least 2 days with the simultaneous presence of Young Mania Rating Scale (YMRS) score>/=14 PLUS Montgomery Asberg Depression Rating Scale (MADRS) score>/=14 ;
Patients meeting DSM-IV TR diagnostic criteria for a major depressive episode with the simultaneous presence of MADRS score>/=14 PLUS meeting the criteria for a manic/hypomanic episode for at least 2 days with the simultaneous presence of Young Mania Rating Scale (YMRS) score>/=14

Exclusion Criteria

Patients with a current Axis I diagnosis of schizophrenia, schizophreniform disorder, schizotypal disorder, bipolar disorder with psychotic subtype, drug induced mania or AIDS induced mania
Women with a positive pregnancy test or who are lactating
Women of child-bearing potential who are not practicing a clinically accepted method of contraception
Patients with general medical conditions that contraindicate psychoactive medications or uncontrolled medical disorder or central nervous system diseases.
Patients whose clinical status requires inpatient or day hospital treatment
History of severe side effects associated with therapeutic doses of Li, DIV, LAM
Alcohol or drug dependent at time of enrollment
Suicidal at time of enrollment.
Current or previous exposure to QTP

Arm && Interventions

Group	Intervention	Description
quetiapine SR	quetiapine SR	quetiapine SR, 200-600mg, po, qd
quetiapine sr Placebo	quetiapine sr placebo	quetiapine SR placebo, 200-600mg, po qd

Primary Outcome Measures

Name	Time	Method
Number of Patients Whose Mood Improved According to MADRS and YMRS Scale Scores.	Baseline visit to week 24	The primary outcome measure was assessed by 50% reduction in: 1. depression scores on the Montgomery Asberg Depression Rating Scale (MADRS), which ranges from 0 indicating no symptoms to 60 indicating most symptoms 2. mania scores on the Young Mania Rating Scale (YMRS), which ranges from 0 indicating no symptoms to 60 indicating most symptoms.

Secondary Outcome Measures